MAUDE Adverse Event Report: COVIDIEN LP MULTIFIRE PREMIUM; STAPLE, REMOVABLE (SKIN)

Model Number 059037

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

The medical student was using the multifire premium auto suture pistol grip skin stapler to close the wound.While using the stapler, the plastic piece covering the staple load fell off.The scrub tech attempted to replace the piece, but it would not remain on.The stapler was removed from the field and a new stapler was opened to completed wound closure.

• Brand Name: MULTIFIRE PREMIUM
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15248640
• MDR Text Key: 298125553
• Report Number: 15248640
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 059037
• Device Catalogue Number: 059037
• Device Lot Number: J2F0444Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1